Montgomery-Åsberg Depression Rating Scale (MADRS) score decreasing by \>50%
Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care
Brief Summary
This is a phase 2 study of the drug ketamine for the treatment of depression in cancer patients receiving palliative care. The purpose of this study is to see how useful the drug is at decreasing the severity of depression these patients. Ketamine will be given through the nose.
Intervention / Treatment
-
Ketamine Hydrochloride (DRUG)Ketamine is a N-methyl-D-aspartate (NMDA) antagonist.
Condition or Disease
- Depression
- Cancer
- Palliative Care
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 22 (ACTUAL) |
| Funded by: | Other |
| Allocation: | N/A |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Jul 16, 2018 | ACTUAL |
|---|---|---|
| Primary Completion: | Nov 27, 2021 | ACTUAL |
| Completion Date: | Nov 27, 2021 | ACTUAL |
| Study First Posted: | Jan 25, 2018 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | May 04, 2022 |
Sponsors / Collaborators
Lead Sponsor:
University Health Network, Toronto
Lead sponsor is responsible party
Responsible Party:
N/A
Location
Participant Groups
-
Three doses of ketamine will be given intranasal: * Dose 1 will be 50 mg on Day 1 * Dose 2 will be between 50-100 mg on Day 4 * Dose 3 will be between 50-150 mg on Day 7
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* Provide written, voluntary informed consent prior to study enrollment. Participants must be capable of consenting to treatment as substitute decision makers will not be allowed to consent to the study on their behalf
* Males and females ≥ 18 years of age
* Patient is receiving palliative care at Princess Margaret Cancer Centre (PM) including all in-patient units and outpatients
* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Major Depressive Disorder (MDD), with a current Major Depressive Episode (MDE)
* Depression severity must be in the moderate to severe range, as determined by a Montgomery-Åsberg Depression Rating Scale (MADRS) score greater than or equal to 20
* Participants must have a confirmed diagnosis of cancer and an estimated life expectancy of less than twelve months, as determined by the palliative care physician
Exclusion Criteria:
* Presence of delirium or suspected delirium
* Severe hypertension or severe cardiac decompensation
* Previous stroke history
* History of intolerability, hypersensitivity or allergy to ketamine
* Patients with bipolar disorder, psychotic disorders, substance use disorders or active suicidality based on a Mini-International Neuropsychiatric Interview (MINI) conducted by a delegated physician will also be excluded
* Current symptoms of psychosis or perceptual disturbances of any kind per investigator discretion
* Pregnancy or breastfeeding women
* Provide written, voluntary informed consent prior to study enrollment. Participants must be capable of consenting to treatment as substitute decision makers will not be allowed to consent to the study on their behalf
* Males and females ≥ 18 years of age
* Patient is receiving palliative care at Princess Margaret Cancer Centre (PM) including all in-patient units and outpatients
* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Major Depressive Disorder (MDD), with a current Major Depressive Episode (MDE)
* Depression severity must be in the moderate to severe range, as determined by a Montgomery-Åsberg Depression Rating Scale (MADRS) score greater than or equal to 20
* Participants must have a confirmed diagnosis of cancer and an estimated life expectancy of less than twelve months, as determined by the palliative care physician
Exclusion Criteria:
* Presence of delirium or suspected delirium
* Severe hypertension or severe cardiac decompensation
* Previous stroke history
* History of intolerability, hypersensitivity or allergy to ketamine
* Patients with bipolar disorder, psychotic disorders, substance use disorders or active suicidality based on a Mini-International Neuropsychiatric Interview (MINI) conducted by a delegated physician will also be excluded
* Current symptoms of psychosis or perceptual disturbances of any kind per investigator discretion
* Pregnancy or breastfeeding women
Primary Outcomes
More Details
| NCT Number: | NCT03410446 |
|---|---|
| Other IDs: | INKeD-PC |
| Study URL: | https://clinicaltrials.gov/study/NCT03410446 |
Last updated: Sep 29, 2023